An interventional study of Live-Online M-ROCC and Live-Online Control in Opioid-use Disorder, Stress Related Disorder and Anxiety, sponsored by Cambridge Health Alliance. Completed at 1 site in United States. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2025-07-22.
Sponsored by Cambridge Health Alliance · Not applicable, Interventional, and Treatment
This will be a randomized controlled trial (RCT) designed to compare live-online Mindful Recovery Opioid Care Continuum (M-ROCC) groups with a live-online control group on the primary outcome of number of biochemically confirmed opioid negative abstinent periods (defined by a negative oral fluid test [negative for opiate, oxycodone, fentanyl, methadone] AND no self-reported illicit opioid use) during the final six two-week periods of the study (study weeks 13-24).
The investigators will conduct a RCT comparing Mindful Recovery Opioid Care Continuum (M-ROCC), a 24-week motivationally-responsive, trauma-sensitive, Group-Based Opioid Treatment (GBOT) program to a live-online control group, on the number of biochemically confirmed opioid negative abstinent periods (defined by a negative oral fluid test [negative for opiate, oxycodone, fentanyl, methadone] AND no self-reported illicit opioid use) during the final six two-week periods of the study (study weeks 13-24).
Clinical secondary outcomes include level of anxiety measured by the Patient Reported Outcomes Measurement Information System - Anxiety Short Form 8a (PROMIS-ASF), level of pain interference measured by the PROMIS Pain Interference Scale (PROMIS-PISF), and the number of positive oral fluid tests for BZD or cocaine during the final 12 weeks of the study. Other exploratory outcomes will be level of anxiety measured by the Beck anxiety inventory (BAI), 24-week intervention retention, as well as mechanisms of self-regulation assessed by self-report and behavioral measures (emotion regulation, decentering/metacognitive monitoring, interoception, experiential avoidance, self-critical rumination, and self-compassion) and their mediating effects on anxiety and opioid abstinence. Qualitative interviews will be conducted with a minimum of 12 and a maximum of 25 M-ROCC completers until thematic saturation to examine themes regarding live-online mindfulness delivery and to compare responses with our R21 qualitative outcomes from our in-person M-ROCC group model. Computerized Adaptive Testing for Mental Health (CAT-MH) will be used to assess changes in psychiatric co-morbidity. Finally, exploratory outcomes of stigma, mindfulness, perceived stress, pain catastrophizing, interpersonal conflict, and shared identity within group will be measured.
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Exclusion Criteria:
Live-Online Mindful Recovery OUD Care Continuum (M-ROCC) builds on other mindfulness interventions for addictive disorders, but is specifically designed for patients with OUD prescribed buprenorphine to be delivered in a live-online environment. It focuses on integration of mindfulness practice for living well through stress, anxiety, depression, pain and addiction recovery. The live-online M-ROCC curriculum has three primary components, including a low-dose mindfulness phase, an intensive mindfulness training phase and then a mindfulness maintenance check-in support group.
Behavioral: Live-Online M-ROCC
A time- and attention-matched live online control group. The manualized control intervention developed for the basic group-based opioid treatment group in primary care uses 16 core modules and 8 elective modules that are common to eclectic approach in treatment as usual addiction recovery groups (including engagement and group development activities with a mix of basic CBT skills, twelve-step facilitation, community reinforcement, and motivational interviewing). As an active group control, this method will help to isolate mindfulness as the putative mechanism of action by controlling for the therapeutic aspects of group without any reference to mindfulness.
Behavioral: Live-Online Control
1. LDM (Low-Dose Mindfulness): A 4-wk intro mindfulness program for OUD, 50-60 min/week including explicit training in use of mobile mindfulness apps, with rolling admission and ascending practice dose ladder. 2. MTPC (Mindfulness Training for Primary Care): An eight-week intensive mindfulness group with ascending practice dose ladder and skill integration over 16 weeks with 60 minutes/wk. 3. MCS (Mindfulness Maintenance Check-in Support): Ongoing weekly mindfulness group with check-in and reminders, leveraging mobile mindfulness apps and motivational counseling for graduates of LDM for 50-60 mins/wk. After completion of the LDM group, participation in various levels is fluid based on patient motivation, choice, and readiness.
A time- and attention-matched live online control group. The manualized control intervention developed for the basic group-based opioid treatment group in primary care uses 16 core modules and 8 elective modules that are common to eclectic approach in treatment as usual addiction recovery groups (including engagement and group development activities with a mix of basic CBT skills, twelve-step facilitation, community reinforcement, and motivational interviewing). As an active group control, this method will help to isolate mindfulness as the putative mechanism of action by controlling for the therapeutic aspects of group without any reference to mindfulness.
Number of Biochemically-confirmed Opioid Abstinent 2-week Time Periods
Biochemically-confirmed opioid abstinence, which is defined as the number of two-week periods with a negative oral fluid screen AND no opioid use reported in weekly self report self-report during the final 12 weeks (weeks 13-24) of the study (6 is the highest possible number of negative oral fluid toxicology screen time periods). Participants will be randomly selected to undergo a live-online supervised oral fluid screen at a rate of once every 2 weeks.
Time frame: Weeks 13-24
Number of Positive Oral-fluid Toxicology Tests for Cocaine.
Biochemically-confirmed cocaine use, which is defined as the number of two-week periods with a positive oral-fluid screen. Oral-fluid toxicology screens will be conducted during the final 12 weeks (weeks 13-24) of the study (6 is the highest possible number of negative oral fluid toxicology screen time periods). Participants will be randomly selected to undergo a live-online supervised oral fluid screen at a rate of once every 2 weeks.
Time frame: Weeks 13-24
Number of Positive Oral-fluid Toxicology Tests for Benzodiazepines.
Biochemically-confirmed benzodiazepine use, which is defined as the number of two-week periods with a positive oral-fluid screen. Oral-fluid toxicology screens will be conducted during the final 12 weeks (weeks 13-24) of the study (6 is the highest possible number of negative oral fluid toxicology screen time periods). Participants will be randomly selected to undergo a live-online supervised oral fluid screen at a rate of once every 2 weeks.
Time frame: Weeks 13-24
Patient Report Outcomes Measurement Information System - Anxiety Short Form 8a (PROMIS-ASF)
The Patient Reported Outcomes Measurement Information System - Anxiety Short Form 8a (PROMIS-ASF) is an 8-item scale from 7-35 used to assess patient-reported health status for anxiety. Subjects are asked to rate their experience of the item in the past seven days on a 5-point scale from 1 (Never) to 5 (Always). Higher ratings indicate greater anxiety symptoms while lower ratings indicate less anxiety symptoms. This will be assessed among participants with an anxiety disorder (defined as PROMIS \>55 at baseline) as well at weeks 8, 16, and 24.
Time frame: 24 Weeks
Pain Interference PROMIS (PROMIS-PISF)
The PROMIS Pain Interference instruments measure the self-reported consequences of pain on relevant aspects of one's life. This includes the extent to which pain hinders engagement with social, cognitive, emotional, physical, and recreational activities. The Pain Interference short form is universal rather than disease-specific. It assesses pain interference over the past seven days. Each question has five response options ranging in value from one to five with a total scale range of 7-35. Higher ratings indicate greater pain interference and lower ratings indicate lesser pain interference. This assessment was done at baseline and weeks 8, 16, and 24.
Time frame: 24 Weeks
Substance Craving Scale (SUBCS)
The Substance Craving Scale (SUBCS) is a 6-item scale with a range of 0-60. It includes the 3-item validated Opioid Craving Scale (OCS) as the primary measure with a 0-30 scale based on opioids. The SUBCS adds another 3 items based on other non-opioids substances. The OCS assesses participant craving for Opioids (including fentanyl, heroin, methadone, oxycodone or other opioids) and the (SUBCS) includes the OCS plus other substance use (including illicit drugs \[e.g., cocaine, methamphetamine, etc.\], using unprescribed pills or prescribed medications in ways or at doses for which they were not prescribed \[e.g., Klonopin, etc.\], or drinking alcohol). This study uses the 3-items specifically from the Opioid Craving Scale (OCS) as our outcome measure for this study with a range of 0-30 and includes SUBCS as exploratory. Higher ratings on OCS indicate greater opioid craving and lower ratings indicate less opioid craving.
Time frame: 24 Weeks
Participants were recruited through Facebook, community partners (e.g., Lynn Community Health, Boston Medical Center, North Shore Community Health), online telemedicine providers (e.g., Bicycle Health, Boulder Care), and QR-code flyers linking an online referral form. Participants were recruited from 16 states including Massachusetts, Florida, Vermont, New Hampshire, Connecticut, New York, Maine, Texas, Rhode Island, California, North Carolina, Illinois, Michigan, Virginia, Alabama, and Arizona.
| Milestone | Live-Online Mindful Recovery OUD Care Continuum | Live-Online Control |
|---|---|---|
| Started | 98 | 98 |
| Completed | 48 | 68 |
| Not completed | 50 | 30 |
| Withdrew: Withdrawal by subject | 13 | 6 |
| Withdrew: Lost to follow-up | 37 | 24 |
Biochemically-confirmed opioid abstinence, which is defined as the number of two-week periods with a negative oral fluid screen AND no opioid use reported in weekly self report self-report during the final 12 weeks (weeks 13-24) of the study (6 is the highest possible number of negative oral fluid toxicology screen time periods). Participants will be randomly selected to undergo a live-online supervised oral fluid screen at a rate of once every 2 weeks.
| percentage of 2-week time periods | Live-Online Mindful Recovery OUD Care Continuum | Live-Online Control |
|---|---|---|
| Number of Biochemically-confirmed Opioid Abstinent 2-week Time Periods | 13.4 (6.2 to 20.5) | 12.7 (7.5 to 18.0) |
Biochemically-confirmed cocaine use, which is defined as the number of two-week periods with a positive oral-fluid screen. Oral-fluid toxicology screens will be conducted during the final 12 weeks (weeks 13-24) of the study (6 is the highest possible number of negative oral fluid toxicology screen time periods). Participants will be randomly selected to undergo a live-online supervised oral fluid screen at a rate of once every 2 weeks.
| percentage of 2-week time periods | Live-Online Mindful Recovery OUD Care Continuum | Live-Online Control |
|---|---|---|
| Number of Positive Oral-fluid Toxicology Tests for Cocaine. | 8.4 (0 to 16.6) | 1.5 (0 to 4.0) |
Biochemically-confirmed benzodiazepine use, which is defined as the number of two-week periods with a positive oral-fluid screen. Oral-fluid toxicology screens will be conducted during the final 12 weeks (weeks 13-24) of the study (6 is the highest possible number of negative oral fluid toxicology screen time periods). Participants will be randomly selected to undergo a live-online supervised oral fluid screen at a rate of once every 2 weeks.
| percentage of 2-week time periods | Live-Online Mindful Recovery OUD Care Continuum | Live-Online Control |
|---|---|---|
| Number of Positive Oral-fluid Toxicology Tests for Benzodiazepines. | 22.1 (12.7 to 31.5) | 20.2 (12.7 to 27.7) |
The Patient Reported Outcomes Measurement Information System - Anxiety Short Form 8a (PROMIS-ASF) is an 8-item scale from 7-35 used to assess patient-reported health status for anxiety. Subjects are asked to rate their experience of the item in the past seven days on a 5-point scale from 1 (Never) to 5 (Always). Higher ratings indicate greater anxiety symptoms while lower ratings indicate less anxiety symptoms. This will be assessed among participants with an anxiety disorder (defined as PROMIS \>55 at baseline) as well at weeks 8, 16, and 24.
| differences in scores on a scale | Live-Online Mindful Recovery OUD Care Continuum | Live-Online Control |
|---|---|---|
| Patient Report Outcomes Measurement Information System - Anxiety Short Form 8a (PROMIS-ASF) | -9.0 (-11.7 to -6.3) | -10.0 (-12.0 to -8.0) |
The PROMIS Pain Interference instruments measure the self-reported consequences of pain on relevant aspects of one's life. This includes the extent to which pain hinders engagement with social, cognitive, emotional, physical, and recreational activities. The Pain Interference short form is universal rather than disease-specific. It assesses pain interference over the past seven days. Each question has five response options ranging in value from one to five with a total scale range of 7-35. Higher ratings indicate greater pain interference and lower ratings indicate lesser pain interference. This assessment was done at baseline and weeks 8, 16, and 24.
| differences in scores on a scale | Live-Online Mindful Recovery OUD Care Continuum | Live-Online Control |
|---|---|---|
| Pain Interference PROMIS (PROMIS-PISF) | -4.1 (-7.3 to -0.9) | -4.4 (-6.8 to -2) |
The Substance Craving Scale (SUBCS) is a 6-item scale with a range of 0-60. It includes the 3-item validated Opioid Craving Scale (OCS) as the primary measure with a 0-30 scale based on opioids. The SUBCS adds another 3 items based on other non-opioids substances. The OCS assesses participant craving for Opioids (including fentanyl, heroin, methadone, oxycodone or other opioids) and the (SUBCS) includes the OCS plus other substance use (including illicit drugs \[e.g., cocaine, methamphetamine, etc.\], using unprescribed pills or prescribed medications in ways or at doses for which they were not prescribed \[e.g., Klonopin, etc.\], or drinking alcohol). This study uses the 3-items specifically from the Opioid Craving Scale (OCS) as our outcome measure for this study with a range of 0-30 and includes SUBCS as exploratory. Higher ratings on OCS indicate greater opioid craving and lower ratings indicate less opioid craving.
| score on a scale | Live-Online Mindful Recovery OUD Care Continuum | Live-Online Control |
|---|---|---|
| Substance Craving Scale (SUBCS) | -2.3 (-2.9 to -1.7) | -1.3 (-1.9 to -0.8) |
Collected over Adverse event data were collected over the 24 weeks that participants were in the study.. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Live-Online Mindful Recovery OUD Care Continuum | — | 7/98 (7.1%) | 29/98 (29.6%) |
| Live-Online Control | — | 2/98 (2%) | 21/98 (21.4%) |
| Event | Live-Online Mindful Recovery OUD Care Continuum | Live-Online Control |
|---|---|---|
| InfectionInfections and infestations | 3/98 | 0/98 |
| PneumoniaRespiratory, thoracic and mediastinal disorders | 1/98 | 0/98 |
| Heart and Lung ProblemsCardiac disorders | 0/98 | 1/98 |
| OverdosePsychiatric disorders | 1/98 | 0/98 |
| Covid-19Immune system disorders | 1/98 | 0/98 |
| SurgerySurgical and medical procedures | 0/98 | 1/98 |
| MiscarriageReproductive system and breast disorders | 1/98 | 0/98 |
| Event | Live-Online Mindful Recovery OUD Care Continuum | Live-Online Control |
|---|---|---|
| Worsening Psychiatric Symptoms/StressPsychiatric disorders | 7/98 | 5/98 |
| Developed a new conditionGeneral disorders | 5/98 | 1/98 |
| PainGeneral disorders | 4/98 | 5/98 |
| SicknessImmune system disorders | 2/98 | 3/98 |
| InjuryInjury, poisoning and procedural complications | 3/98 | 2/98 |
| PregnancyReproductive system and breast disorders | 0/98 | 3/98 |
| Stomach IssuesGastrointestinal disorders | 2/98 | 1/98 |
| HeadachesNervous system disorders | 2/98 | 0/98 |
| Cardiac IssuesCardiac disorders | 1/98 | 0/98 |
| Kidney stonesRenal and urinary disorders | 1/98 | 1/98 |
This study used an intent-to-treat analysis model. Therefore, all participants that were randomized were included in the analysis.
| Age, Categorical(Participants) | Live-Online Mindful Recovery OUD Care Continuum | Live-Online Control | Total |
|---|---|---|---|
| <=18 years | 0 | 0 | 0 |
| Between 18 and 65 years | 97 | 95 | 192 |
| >=65 years | 1 | 3 | 4 |
| Age, Continuous(years) | Live-Online Mindful Recovery OUD Care Continuum | Live-Online Control | Total |
|---|---|---|---|
| Mean | 42.2 ± 10.4 | 40.9 ± 10.3 | 41.0 ± 10.3 |
| Sex: Female, Male(Participants) | Live-Online Mindful Recovery OUD Care Continuum | Live-Online Control | Total |
|---|---|---|---|
| Female | 60 | 59 | 119 |
| Male | 38 | 39 | 77 |
| Ethnicity (NIH/OMB)(Participants) | Live-Online Mindful Recovery OUD Care Continuum | Live-Online Control | Total |
|---|---|---|---|
| Hispanic or Latino | 10 | 6 | 16 |
| Not Hispanic or Latino | 88 | 91 | 179 |
| Unknown or Not Reported | 0 | 1 | 1 |
| Race (NIH/OMB)(Participants) | Live-Online Mindful Recovery OUD Care Continuum | Live-Online Control | Total |
|---|---|---|---|
| American Indian or Alaska Native | 1 | 0 | 1 |
| Asian | 0 | 1 | 1 |
| Native Hawaiian or Other Pacific Islander | 1 | 0 | 1 |
| Black or African American | 1 | 0 | 1 |
| White | 90 | 90 | 180 |
| More than one race | 2 | 3 | 5 |
| Unknown or Not Reported | 3 | 4 | 7 |
| Marital Status(Participants) | Live-Online Mindful Recovery OUD Care Continuum | Live-Online Control | Total |
|---|---|---|---|
| Single | 43 | 44 | 87 |
| Married or Living as Married | 29 | 37 | 66 |
| Divorced | 18 | 14 | 32 |
| Widowed | 6 | 3 | 9 |
| Other | 2 | 0 | 2 |
| Education (years)(years) | Live-Online Mindful Recovery OUD Care Continuum | Live-Online Control | Total |
|---|---|---|---|
| Mean | 13.1 ± 2.2 | 13.5 ± 2.6 | 13.3 ± 2.4 |
| Sexual Identity(Participants) | Live-Online Mindful Recovery OUD Care Continuum | Live-Online Control | Total |
|---|---|---|---|
| Straight or Heterosexual | 81 | 78 | 159 |
| Lesbian, Gay, or Homosexual | 3 | 6 | 9 |
| Bisexual | 9 | 10 | 19 |
| Other | 5 | 4 | 9 |
12 further baseline measures are reported on the registry.
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